SK pneumococcal conjugate vaccine nears global entry

9 yrs after initial joint development agreement

SK bioscience and Sanofi have submitted Phase 3 IND to FDA for pneumococcal conjugate vaccine co-development

Joint development since 2014… Following successful Phase 2 study completion, last phase of testing to be launched

81.5 billion won invested pneumococcal conjugate vaccine commercialization production facility to be built

SK Bioscience is fast-tracking its global market strategy for its next-generation pneumococcal vaccine.

 

Nine years following the start of their joint development with Sanofi, the company has now progressed to the last phase of clinical trials for commercialization.

 

SK Bioscience has also been improving its vaccine production facilities to prepare for the commercial manufacturing of pneumococcal vaccines.

 

SK Boscience announced on 11th that SK Bioscience and Sanofi have submitted a Phase 3 Investigational New Drug application (IND) to the U.S.

 

Food and Drug Administration (FDA) for its jointly developed 21-valent pneumococcal conjugate vaccine candidate, GBP410 (Sanofi’s project name: SP0202).

 

SK Bioscience and Sanofi aim to enroll infants from various nations including the US, Europe, and Korea and complete Phase III clinical trials by 2027.

 

In March 2014, SK Bioscience signed an agreement with Sanofi to jointly develop and commercialize an next-generation pneumococcal vaccine.

 

The companies have rogressed to the last phase of clinical studies for the vaccine’s commercialization, nine years after signing the joint development agreement.

 

GBP410 is a protein conjugate vaccine that combines specific proteins with the polysaccharide capsule of Streptococcus pneumoniae, which causes pneumonia and invasive pneumococcal disease.

 

The conjugate vaccines are well known to provide superior protection among pneumococcal vaccines developed to date.

 

GBP410s anticipated to offer broader protection over existing pneumococcal vaccines, given that it includes 21 serotypes.

 

Serotypes are one of the key pathogenic factors in pneumococcal bacteria, and different serotypes are associated with varying pathogenicity.

 

The newly introduced pneumococcal vaccine in Korea helps protect against 15 serotypes.

 

SK Bioscience and Sanofi are preparing to commence the Phase 3 clinical study based on the successful completion of their Phase 2 clinical study of GBP410, The Phase 2 study by SK Bioscience and Sanofi was commenced in May 2020, enrolling 140 toddlers aged 12 to 15 months and 712 infants aged 42 to 89days from the US, Canada, and Honduras.

 

GBP410 and a comparator vaccine were given to the cohorts as primary vaccination (2·4·6 months of age) and then as a booster vaccination (12-15 months of age).

 

The results demonstrated comparable immunogenicity of GBP410 compared to the comparator vaccine.

 

In terms of safety, no serious vaccine-related adverse reactions were reported in the GBP410-vaccinated group.

 

GBP410 demonstrated equivalent immunogenicity and safety compared to the comparator vaccine when co-administered with recommended vaccines for infants and children, such as those for tetanus, diphtheria, pertussis, polio, and Haemophilus influenzae type B.

 

SK Bioscience

SK Bioscience has also started securing production facilities for GBP410.

 

Last month, the company's board of directors agreed to invest approximately 81.5 billion won to expand their Andong L House vaccine production facility.

 

This expansion, supported by a joint-investment with Sanofi, will lead to the construction of a roughly 45,208 square feet production facility.

 

Once the FDA approves GBP410, SK Bioscience aims to manufacture the vaccine at Andong L House and distribute it to the global market .

 

Once the commercialization of GBP410 is finalized, SK Bioscience plans to also launch the vaccine in Korea.

 

Previously, SK Bioscience suffered defeat in the pneumococcal vaccine market in Korea.

 

In 2016, SK Bioscience gained approval from the Ministry of Food and Drug Safety (MFDS) to market its pneumococcal vaccine, SKYPneumo Prefilled Syringe.

 

SKYPneumo Prefilled Syringe is SK Bioscience's first premium vaccine.

 

The company is positioning premium, next-generation vaccines as a pivotal element in its growth strategy.

 

To achieve this, SK Bioscience has invested approximately 400 billion won in enhancing vaccine business infrastructure and R&D efforts.

 

A significant step in this direction was the completion of the L House in Gyeongbuk Andong, in 2012.

 

This facility stands as the largest vaccine factory in Korea, with an investment of about 200 billion won solely for its construction.

 

After losing a patent lawsuit against Pfizer, SK Bioscience failed to launch SKYPneumo Prefilled Syringe.

 

SK Bioscience had contested the validity of Pfizer's patent for PREVENAR 13 Inj by filing a lawsuit.

 

In December 2018, the Supreme Court rejected the suit.

 

Consequently, SKYPneumo Prefilled Syringe cannot be marketed until the Prevnar 13's patent expires in 2026.

 

In response, SK Bioscience voluntarily withdrew the license for SKYPneumo Prefilled Syringe in 2020 but reacquired it the following year.

 

“We are getting closer to successfully developing the pneumococcal conjugate vaccine that only few of the world’s top vaccine companies have succeeded in,” said Ahn Jaeyong, CEO of SK Bioscience.

 

With 740,000 infants, children, and adolescents dying from pneumonia every year, we seek to contribute to global public health and rise to become a market-leading company by successfully developing GVP410."